Labelling as driver for Regulatory Strategy

After completion of the course, the participants will be able to:

Knowledge

• Explain and describe the roles and the responsibilities of a regulatory lead professional in the pharmaceutical industry
• Identify what a regulatory strategy should contain, including general and context specific content
• Explain and describe why product information is a key driver for approval and market access
• Explain and describe when to use patient reported outcomes, patient and health technology assessment aspects in product information
• Explain and describe various types of scientific advice in e.g. EU, USA, Japan and China during medicines development and throughout the entire life cycle    

Skills:

• Analyze and discuss the roles and the responsibilities of a regulatory lead professional in the pharmaceutical industry
• Analyze and discuss context related challenges in a regulatory strategy and what can be excluded    
• Analyze and discuss why a regulatory lead professional should challenge the product information from early development and throughout the entire life cycle of a product
• Analyze, evaluate and apply the relevance of using patient reported outcomes, patient and health technology assessment aspects in product information
• Discuss when and apply regulatory intelligence and policy work during medicines development and throughout life cycle 
• Analyze, evaluate and apply when to use various types of scientific advice in e.g. EU, USA, Japan and China during medicines development and throughout the entire life cycle   

Competence;

• Independently and in the most efficient manner initiate, critical reflect and drive the development of a regulatory strategy ensuring a strong, reliable quality based story line for product approvals during the entire product life cycle in a collaborative manner
• Independently challenge the related product information statement professional experts in the most efficient and collaborative manner, ensuring evidence based, supporting data
• Independently, critical reflect and drive the development of a competitive, evidence based, approvable product information in the most efficient manner
• Initiate and facilitate good, respectful and efficient relations to global health authorities, as appropriate
• Enabling transparent, regulatory science as contributor to the market access process after regulatory approval